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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K171695
Device Name First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana
Applicant
W.H.P.M., Inc.
5358 Irwindale Ave.
Irwindale,  CA  91706
Applicant Contact John Wan
Correspondent
Lsi Consulting
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
LDJ   NFY   NGG  
Date Received06/07/2017
Decision Date 02/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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